The present invention generally relates to pharmacy containers, and more specifically to a biodegradable pharmacy container and safety cap.
Currently, pharmacy containers are made from plastic, such as poly propylene, are lightweight, can be molded easily at low cost, and are widely used, but plastic has negative environmental impacts. Propylene and other plastics are derived from petroleum, or are otherwise fossil fuel based, which is not readily biodegradable, nor renewable or sustainable, and has a large carbon footprint.
A “bioplastic” can be biodegradable, and is shaped by being formed, molded or extruded into a desired shape.
Biodegradable products may be made from paper or bioplastic, and from biodegradable or bioplastic resins. Bioplastic resins may include polyhydroxyalkonate (PHA), poly 3 hydroxybutrate co 3 hydroxyhexanote (PHBH), polyhydroxybutyrate-co-valerate (PHB/V), poly-3-hydroxybutyrate (PHB), chemical synthetic polymer such as polybutylene succinate (PBS), polybutylene succinate adipate (PBSA), polybutylene succinate carbonate, polycaprolactone (PCL), cellulose acetate (PH), polylactic acid/chemical synthetic polymer such as polylactic polymer (PLA) or copoly-L-lactide (CPLA), and naturally occurring polymer, such as starch modified PVA+aliphatic polyester, or corn starch.
Bioplastics are plant based and are compostable, thus biodegradable, and are from a renewable, sustainable resource, which has a lower carbon foot print than ordinary plastic. For these reasons bioplastics are more environmentally friendly than plastic.
The United States Pharmacopeial Convention has established requirements for containers which are described in many of the drug product monographs in The United States Pharmacopeia/National Formulary (USP/NF). For capsules and tablets, these requirements generally relate to the design characteristics of the container, e.g., tight, well-closed or light-resistant.
The Food and Drug Administration (FDA) has requirements for tamper-resistant closures and the Consumer Product Safety Commission (CPSC) has requirements for child-resistant closures. For capsules and tables, these requirements generally require containers that are tight, well-closed or light-resistant. A packing systems should protect the dosage form, be compatible with the dosage form, and should be composed of materials that are considered safe for use with the dosage form (e.g. generally nontoxic).
To be suitable for storing medicine, a pharmacy container closure system must provide adequate protection from temperature and light that can cause a degradation in the quality of the dosage form over its shelf life. Common causes of such degradation are exposure to light, loss of solvent, exposure to reactive gases (e.g. oxygen), absorption of water vapor, microbial contamination, or contamination by filth. Solid oral dosage forms generally need to be protected from the potential adverse effects of water vapor. Protection from light and reactive gases may also be needed. For example, the present of moisture may affect the decomposition rate of the active drug substance or the dissolution rate of the dosage form. The container should have an intrinsically low rate of water vapor permeation, and the container closure system should establish a seal to protect the drug product.
Clear or translucent grade silicone liquid rubber or plasma, that is hypoallergenic, may be used in a variety of applications. Silicone characteristics include superb chemical resistance, high temperature performance, good thermal, long-term resiliency, and easy fabrication. It also possesses excellent UV resistance. This material may be low volatile, peroxide free and does not discolor over time. Silicone is odorless, tasteless, chemically inert and non-toxic. It may meet standards developed by US Pharmacopeia and offer FDA approved ingredients, including low compression set and fungus resistance.
It would therefore be desirable to provide a pharmacy container and safety cap made from a biodegradable material that is child resistant and elderly friendly. It would be desirable to have a pharmacy closure system that can be used to dispense human drugs, biological, nutraceutical and veterinary products, and at the same time meet standards developed by US Pharmacopeia and meets FDA container guidelines.